Zhaohui Su, VP, Strategic Consulting at Veristat, shared a post on LinkedIn:
“This recent analysis of over 190,000 clinical trials registered from 2004 to 2025 shows that protocol complexity continues to rise.
- Median endpoint counts have more than doubled, increasing from 3 to 7, primarily due to the addition of secondary endpoints.
- Eligibility criteria have become more restrictive across various phases and sponsor types, which may complicate patient recruitment.
- Trial failure rates have increased modestly, from 10.2% to 13.2%.
While more endpoints, stricter eligibility, and enhanced oversight can improve study rigor, they also raise operational burdens, recruitment challenges, timelines, and costs.
As we adopt AI, decentralized trials, real-world evidence (RWE), and continuous regulatory oversight, the focus should be on designing smarter studies rather than simply more complex ones.
How do you balance scientific rigor with operational feasibility and patient-centricity? Please leave a comment, or reach out to Veristat for a conversation.
Source.”
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